Survival Triples For 1000 AIDS Patients Receiving Antiretroviral
Therapy In Haiti, According To Weill Medical College Study
06 Dec 2005
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A thousand patients with AIDS in Haiti who received antiretroviral
therapy had a one-year survival of 87 percent for adults and 98
percent for children, triple the 30 percent one-year survival of
Haitian patients without the therapy -- according to a study authored
by Haitian and U.S. physician-scientists of Weill Medical College of
Cornell University and the GHESKIO Center in Port-au-Prince, Haiti.

The research is being published in the New England Journal of
Medicine on December 1, World AIDS Day. The largest of its kind, the
study provides evidence in support of international efforts to make
antiretroviral therapy available to patients with AIDS in developing
countries.

"Our study demonstrates the feasibility of rapidly and effectively
initiating antiretroviral therapy in a large number of patients in an
impoverished country," says Dr. Jean William Pape, the study's
co-author, an internationally recognized infectious-disease expert,
professor of medicine at Weill Medical College of Cornell University,
and director of GHESKIO. GHESKIO (Groupe Haitien d'Etude du Sarcome
de Kaposi et des Infections Opportunistes) is a Haitian
non-governmental organization (NGO), which works in partnership with
the Haitian government and is dedicated to training, research, and
the provision of HIV/AIDS care. GHESKIO has collaborated with Cornell
University for 25 years.

"Antiretroviral therapy is the international standard of care for
patients with AIDS, and has recently become available in Haiti and in
other developing countries. With limited data on its efficacy in
developing countries, there has been concern that poverty,
malnutrition, tuberculosis, and lack of infrastructure would prove
limiting. Our study showed that these barriers can be overcome," says
Dr. Daniel W. Fitzgerald, the study's senior author and assistant
professor of medicine at Weill Cornell Medical College.

The study examined treatment outcomes of 1,004 AIDS patients
consecutively started on antiretroviral therapy at the GHESKIO clinic
in Port-au-Prince, Haiti, beginning in March 2003, immediately after
international funding for antiretroviral therapy first became
available.

Patients with AIDS at GHESKIO were treated according to World Health
Organization (WHO) guidelines for the use of antiretroviral therapy.
Of the 910 adults and 94 children infected with HIV who received the
three-drug antiretroviral therapy, after one year, 87 percent of
adults survived and 98 percent of children survived. Other measures
of antiretroviral treatment response were also remarkable, including
virologic response rate of 76 percent (the percentage of those with
no presence of HIV in their blood) and a median increase in CD4
T-cell count of 163 per cubic millimeter (an indication of a healthy
immune system) at one year in adults and adolescents.

Importantly, the treatment outcomes in Haiti were comparable to
treatment outcomes achieved in HIV clinics at the best academic
medical centers in the United States.

The care of the 1,004 patients receiving antiretroviral therapy was
supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria;
and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). The
study's authors estimate that the overall cost of treating a patient
with antiretroviral therapy was about $1,600 per year, with
antiretroviral medications accounting for 35 to 45 percent of the
total. The majority of the patients earned less than $1 a day, the
World Bank's international poverty line.

While there have been smaller studies with comparable results in
Africa and Haiti, the current study represents the largest group
studied to date to receive antiretroviral therapy in a developing
nation. Additionally, the study examined patients of all ages
consecutively started on therapy without regard to perceived
likelihood of adherence. The patient population studied is therefore
representative of a clinic population that would be found in other
urban areas severely affected by HIV in the Caribbean or sub-Saharan
Africa.

Haiti is the poorest country in the Western Hemisphere and has
suffered from nearly constant political unrest for the past 20 years.
HIV infection occurs primarily through heterosexual sex, and the
prevalence is currently estimated at 3 percent in the adult
population.

"Poverty, malnutrition, and tuberculosis present serious challenges
to providing antiretroviral therapy in developing countries," says
Dr. Pape. "In response to poverty, we have worked to integrate our
antiretroviral-therapy program with existing social programs that
help give patients access to free care, food, and clean water, and
assist with transportation to and from the clinic. In response to
malnutrition, we provided daily multivitamin supplements to all our
patients who were receiving antiretroviral therapy and a monthly
stock of rice, beans, and vegetable oil to the most undernourished
patients. In response to tuberculosis, we provided tuberculosis
treatment on-site at our clinic."

Continues Dr. Pape: "The single greatest logistical challenge was
maintaining the supply of antiretroviral drugs. Delays in delivery
resulted in a change in the antiretroviral-therapy regimen for 7
percent of our patients. Developing reliable manufacturing and
distribution systems for antiretroviral drugs is an urgent
international priority."

The study is one of the first to examine treatment outcomes of
children with AIDS in a developing country. Dr. Peter Wright of
Vanderbilt University was a co-author and lent the study his
expertise in pediatric HIV care.

"There are a number of other intangible factors that significantly
contributed to the successful implementation of this program,
including continuity of leadership, international collaborations, and
dedicated GHESKIO personnel," says Dr. Warren D. Johnson, co-author,
chief of the Division of International Medicine and Infectious
Diseases and B.H. Kean Professor of Tropical Medicine at Weill
Cornell, and attending physician at NewYork-Presbyterian
Hospital/Weill Cornell Medical Center.

Notably, the first eight authors of the study, including the study's
lead author, Dr. Patrice Severe, are Haitian physicians at GHESKIO
and recipients of training from Weill Medical College of Cornell
University. They also include Drs. Paul Leger, MacArthur Charles,
Francine Noel, Gerry Bonhomme, Gyrlande Bois, Erik George, and Stefan
Kenel-Pierre. Dr. Charles is an infectious-disease fellow and Dr.
George is a pediatric infectious-disease fellow -- both at Weill
Medical College. Dr. Roy Gulick of Weill Cornell also co-authored the
paper.

"The Haitian clinical team are heroes," says Dr. Fitzgerald. "They
were on the front lines every day providing treatment to poor AIDS
patients in the slums of Port-au-Prince, even during times of violent
political unrest. This study documents the results of their hard work
and dedication."

Additional funding for the study included the National Institute of
Allergy and Infectious Diseases (NIAID) and Fogarty International
Center -- both part of the National Institutes of Health (NIH).

Weill Medical College of Cornell University
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